Vaginal Progesterone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With Sonographic Short Cervix

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02338830

Enrollment

182

Registered

2015-01-14

Start date

2012-06-30

Completion date

2014-11-30

Last updated

2015-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Labour

Keywords

Twins, Preterm labor, Progesterone, Short cervix

Brief summary

To evaluate the value of vaginal progesterone therapy for reduction of preterm labor in asymptomatic twin pregnancies who have sonographic short cervix

Detailed description

Women with twin pregnancy with transvaginal sonographic cervical length of 20-25 mm at 20-24 weeks gestational age without symptoms, signs or other risk factors of preterm labor will be included in the study. All women will be randomly divided into two groups; one group (study group) received vaginal progesterone suppositories in a dose of 400 mg daily beginning at 20-24 weeks gestational age (study group) and the other group received no treatment (control group)

Interventions

DRUGProgesterone

Women received vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) in a dose of 400 mg daily beginning at 20-24 weeks gestational age

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 35 Years

Healthy volunteers

Inclusion criteria

* Women pregnant in dichorionic twins. * Transvaginal sonographic cervical length is 20-25 mm at 20-24 weeks gestational age. * No symptoms, signs or other risk factors for preterm labor.

Exclusion criteria

* Age \< 20 years or \> 35 years. * Known allergy or contraindication (relative or absolute) to progesterone therapy. * Pregnancy by in vitro fertilization (IVF) / intracytoplasmic sperm injection (ICSI). * Monochorionic twins. * Known major fetal structural or chromosomal abnormality. * Intrauterine death of one fetus or death of both fetuses. * Fetal reduction in current pregnancy. * Cervical cerclage in current pregnancy. * Medical conditions that may lead to preterm delivery. * Rupture of membranes. * Vaginal bleeding.

Design outcomes

Primary

Measure	Time frame
Preterm labor before 34 weeks	Up to 34 weeks gestational age

Secondary

Measure	Time frame
Neonatal respiratory distress syndrome (RDS)	At birth
Early neonatal death (END).	One month after birth

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026